A Comparison of Stryker Hybrid Arch Bars

Not Applicable

Completed

• Conditions: Fracture Mandible
• Interventions: Device: Stryker Hybrid; Device: Erich

• Registration Number: NCT02283528
• Lead Sponsor: Emory University

Brief Summary

Patients who sustain a fracture of the lower jaw are typically treated by wiring the teeth together or using small titanium plates and screws to fix the fracture. With either technique the upper and lower teeth are held together to ensure that the fracture is held in the correct position during healing (for closed reduction) or while the plate and screws are applied (for open reduction).

The teeth can be held together using Erich arch bars which are a type of braces that are temporarily wired to the existing teeth. These stay in place for 6 weeks until the fracture has healed even though the patient is able to open his mouth immediately after the surgery is complete. The alternative to the traditional Erich arch bars is a relatively new type of arch bar (Stryker Hybrid) that is screwed to the jaw bone rather than wired to the teeth. The purpose of this study is to compare the two types of arch bars in terms of the speed with which they can be applied as well as any difference in fracture healing

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-25
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Study Start: 2015-05
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-21
• Results First Submitted: 2018-10-17
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-11
• Last Update Submitted: 2019-01-11
• Results First Posted: 2019-01-14
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Mandible fracture involving subcondyle, ramus, angle, body, parasymphysis and symphysis
2. Age 18 years - 90 years
3. Ability to give informed consent
4. Minimum 6 weeks follow-up
5. Pre and post-operative panoramic xrays

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Exclusion Criteria

1. Comminuted fractures
2. Infected fractures
3. Previously treated fractures
4. Complete edentulism
5. Gun shot wounds
6. Pregnancy or breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid	Stryker Hybrid	Placement of Hybrid arch bars for open or closed reduction of mandible fractures
Erich	Erich	Placement of Erich archbars for open or closed reduction of mandible fractures

Primary Outcome Measures

Name	Time	Method
Time to Place Archbars	During initial admission and surgery	Time taken to place archbars

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures	up to 6 weeks post operatively	assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures
Number of Participants With Fracture Healing at 6 Weeks	6 weeks	Radiographic healing

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States